Pilot Study of Fenofibrate for PSC

University of Miami

Status and phase: Terminated; Phase 2; Phase 1

Conditions: Primary Sclerosing Cholangitis

Treatments: Drug: fenofibrate

Study type: Interventional

Funder types: Other

Identifiers

NCT01142323

20100533

Details and patient eligibility

About

The purpose of this study is to determine whether fenofibrate is safe and effective in the treatment primary sclerosing cholangitis (PSC).

Enrollment: 8 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male and female patients of 18 to 75 years old
• Confirmed diagnosis of PSC including typical findings of stricturing and dilatations of the intra and/or extrahepatic biliary ducts in radiographic exam, (endoscopic retrograde cholangiopancreatography -ERCP, percutaneous cholangiogram - PTC or magnetic resonance cholangiopancreatography- MRCP)
• Serum alkaline phosphatase levels elevated to at least 1.5 times the upper limit of normal.

Exclusion criteria

• Hypersensitivity to fenofibrate
• Prisoners and institutionalized subjects
• Pregnant or nursing women
• Anticipated need for liver transplantation in one year
• Recipients of liver transplantation
• Recurrent variceal hemorrhage, uncontrolled encephalopathy or refractory ascites
• Co-existing liver diseases including auto-immune and viral hepatitis
• Acute or chronic renal failure, defined as glomerular filtration rate (GFR)< 60 ml/min, GFR calculated using the Modification of Diet in Renal Disease (MDRF) GFR calculator
• Known cholecystitis
• Current use of statins
• Current use of coumadin anticoagulant therapy
• Previous history of, or known high risk for, venous thromboembolism,

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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8 participants in 1 patient group

Fenofibrate

Experimental group

Description:

fenofibrate 160 mg po daily

Treatment:

Drug: fenofibrate